Know Cancer

or
forgot password

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma


Phase 2
1 Year
N/A
Not Enrolling
Both
Malignant Mesothelioma

Thank you

Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma


OBJECTIVES:

- Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV
mesothelioma.

- Describe the response to, tolerance to, and side effects of this regimen in these
patients.

OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 IV six times per day until the maximum dose is reached.

Treatment continues for at least 3 months in the absence of disease progression or
unacceptable toxicity. After 3 months, patients with stable or responding disease may
continue treatment. Patients achieving complete response (CR) continue treatment for at
least 8 months beyond CR.

Patients are followed every 2 months for 1 year and then every 3 months for the second year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV mesothelioma that is unlikely to respond to
existing therapy and for which no curative therapy exists

- Evidence of disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 1 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

- Hepatic function adequate

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal insufficiency

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No uncontrolled hypertension

- No history of congestive heart failure

- No cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- Not at high medical or psychiatric risk

- No nonmalignant systemic disease

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulatory agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplastons

- No other concurrent antineoplastic agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements taken at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

Unspecified

Study ID:

CDR0000066551

NCT ID:

NCT00003508

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

Name

Location

Burzynski ClinicHouston, Texas  77055-6330